FAIRFAX MEDICAL PRODUCTS LIMITED

Fairfax Medical Products Limited specialises in dental devices, primarily producing anaesthesia injection kits and a range of dentine pin kits. Their portfolio includes systems like Stabident and STABILOK, which are designed for endodontic treatments and dental restorations. These devices are tailored for specific procedures in dentistry, ensuring precision and safety during use.

Fairfax Medical Products Limited is headquartered in the United Kingdom. This location allows the company to comply with regulatory standards applicable in the European Economic Area while also supporting its presence in other markets, such as the United States.

Fairfax Medical Products Limited’s devices are listed in the EUDAMED database under the EU Medical Device Regulations, and their products are also registered in the FDA’s Unique Device Identification (UDI) system. These listings ensure transparency and traceability for authorised devices in both the European Economic Area and the United States.

Fairfax Medical Products Limited’s devices are classified under the EU Medical Device Regulations as either Class I or Class IIa. The classification depends on factors like the intended use, risk associated with the device, and the clinical context—such as whether the device is used in direct contact with tissues or for critical procedures. Class IIa devices, like some of their dentine pin kits, carry a higher risk profile than Class I and require additional scrutiny to ensure safety and performance.